JP2005177483A - Method for implanting flexible injection port - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method for implanting an injection port for implantation, permitting puncture of a hypodermic needle regardless of the direction of the injection port to be self-sealed when the needle is pulled out. <P>SOLUTION: The method for hypodermically implanting the injection port to be used together with a medical apparatus for implantation is provided. The method comprises a step for preparing the injection port comprising a first end part, a second end part, a wall part extending between the end parts to be self-sealed after the puncture, a substantially soft and flexible slender body with a fluid reservoir surrounded by the wall part, and a flexible slender tube catheter attached to the slender body to communicate with the reservoir. The method also comprises a step for forming an incision part inside the body of a patient, a step for accessing a subcutaneous fat layer of the patient via the incision part, and a step for implanting the injection port in the subcutaneous fat layer by forming a space in the subcutaneous fat layer so that the injection port can be confirmed by the palpation from outside. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to the field of medicine, and more particularly, medically surgically implanted in a patient's body, particularly suitable for implantable infusion ports used for chemotherapy and adjustable gastric band procedures. Relates to the device.

  Surgeons routinely implant subcutaneous injection ports in the body of patients who need to infuse fluid regularly over time, such as for chemotherapy and gastric band adjustment. This infusion port is connected to a flexible tube catheter to transfer fluid to the affected area (such as the subclavian vein) or gastric band. Current injection ports include a hard metal or plastic housing with a diameter of about 25 mm and a height of 15 mm. A thick silicone septum in a rigid housing covers the inner chamber that communicates with the catheter.

  In general, the surgeon secures the injection port with a suture to the fascia below the skin and fat layers, primarily to prevent inversion of the injection port and to prevent the injection port from moving within the body. . Since the septum can only be accessed from one side of the injection port, if the injection port is flipped, it is necessary to reposition the injection port with a surgical procedure.

  In some patients, the surgeon may implant the injection port in the lower abdomen, in which case the injection port will be implanted under the fat layer, which can be several centimeters thick. Usually, the surgeon can locate the injection port by palpation alone. However, if there is a thick fat layer that interferes, such as extremely obese gastric band patients, the surgeon must also use fluoroscopy, ultrasound, or other means when placing the port. In addition, the surgeon must pierce the needle in a direction generally perpendicular to the injection port and hit the target area of the septum that is only 12-15 mm in diameter. In some patients, the surgeon may place an injection port in the sternum or right upper chest just below the skin layer. Although it is easy to confirm the position by palpation, the protruding port may be uncomfortable or cosmetically uncomfortable depending on the patient.

  Accordingly, there is a need for an injection port for subcutaneous implantation that is formed from a relatively soft flexible material and ideally looks like a thick natural blood vessel (compared to current injection ports). There is also a need for an implantable injection port that can be inserted with a hypodermic needle regardless of the orientation of the injection port in the body tissue and self-sealing when the needle is removed. There is a further need for an injection port for subcutaneous implantation that allows a surgeon to be placed in the body more quickly with a smaller incision than is necessary for a conventional injection port.

  In accordance with the present invention, a method is provided for subcutaneously implanting an injection port for use with an implantable medical device. The method substantially includes a first end, a second end, a wall extending between the ends and self-sealing after insertion, and a fluid reservoir surrounded by the wall. A spp is provided that provides an infusion port including a soft, flexible elongate body and a flexible elongate tube catheter attached to the elongate body in communication with the reservoir. The method further includes the steps of forming an incision in the patient's body, accessing the patient's subcutaneous fat layer through the incision, and externally palpating to confirm the injection port. Forming a space therein and implanting an injection port in the subcutaneous fat layer.

  There is provided a method of subcutaneously implanting an implantable injection port that can be inserted with a hypodermic needle regardless of the orientation of the injection port and self-sealing when the needle is removed.

  It illustrates particularly novel features of the invention as defined in the appended claims. However, the structure and method of the present invention may be better understood by reading the following detailed description with reference to the accompanying drawings.

  Referring to the drawings, a prior art injection port 10 is shown in FIGS. The injection port 10 is typically a frustoconical structure and includes a body portion 12, a housing 14, a seal member 16, and a catheter portion 18. The main body portion 12 is made of a rubberized flexible material and has a cavity 20 inside. A catheter support portion 22 is formed integrally with the main body portion 12. The housing 14 is made of a corrosion resistant metal and has a small inlet passage 24 facing upward. The seal member 16 is made of a rubberized material, can be easily inserted with a hypodermic needle or the like, and provides a seal in which the passage 24 can be inserted. Housing 14 and seal member 16 define an open cavity 20 of injection port 10 for receiving and receiving fluid. The catheter portion 18 extends through the catheter support 22 and the housing 14 of the body portion 12 and into the cavity 20 so that the cavity 20 communicates with the exterior of the injection port 10, thereby allowing fluid to enter the cavity 20. Can be supplied to the patient's body.

  The surgeon implants the patient's injection port 10 subcutaneously. When injecting a fluid such as a drug or saline, the surgeon inserts a hypodermic needle or the like into the patient so that the tip of the needle passes through the seal member 16 and into the cavity 20. Because the passageway 24 is relatively small, whenever a surgeon introduces fluid into the patient, the needle must be inserted into the seal member 16 through the same local area of the patient's skin and tissue. Accordingly, the seal member 16 may be significantly damaged and eventually leak. Also, local areas of skin and subcutaneous tissue will not heal as desired. Furthermore, since the housing 14 is made of metal, the tip of the needle may be damaged, and the patient's trauma may be increased when the needle is pulled out. Furthermore, since the injection port 10 and the metal housing 14 have a frustoconical structure, the injection port 10 can cause considerable discomfort to the patient, particularly if a portion near the injection port of the patient is accidentally hit or hit. There is. In addition, the frustoconical structure of the injection port 10 creates an unsightly aneurysm on the patient's body. Further, since fluid cannot be introduced into the cavity 20 through the passage 24, the surgeon must pierce the injection port with the needle substantially perpendicular to the skin. Thus, the patient's skin or tissue proximity region often cannot effectively support the needle.

  When using the prior art injection port 10 for laparoscopic surgery such as gastric band implantation, the surgeon needs to attach the injection port 10 to the catheter portion 18 during laparoscopic surgery. This is because the injection port 10 is too large to pass through a standard size (12 mm diameter) laparoscopic port used to access the stomach in the abdominal cavity. The surgeon must introduce the gastric band and catheter into the abdominal cavity without attaching the injection port to the free end of the catheter. Once the surgeon has attached the gastric band around the stomach, the surgeon moves the free end of the catheter out of the body through the abdominal muscle, fascial layer, subcutaneous fat layer, and skin, and attaches the free end of the catheter to the injection port. The surgeon then implants the injection port subcutaneously at the desired site in the patient's abdomen or chest. The surgeon must take additional time to connect the injection port to the catheter. The surgeon must also skillfully connect the injection port to the catheter under non-ideal conditions. Thus, complications due to leaks that cannot be found when connecting the catheter to the injection port can occur.

  FIG. 3 is an isometric view of the first embodiment of the present invention showing a flexible injection port or body 30. The flexible injection port 30 typically includes a first end 34, a second end 36, and a tubular injection portion 32 extending therebetween. The surgeon can pierce the injection portion 32 with a hypodermic needle or the like and introduce a fluid such as a drug or saline into the flexible injection port 30. The injection portion 32 is self-sealing when the surgeon withdraws the hypodermic needle. The length of the injection portion 32 is not limited, but ranges from about 5 to 20 cm. The diameter of the injection portion 32 is not limited, but ranges from about 5 to 12 mm. A catheter 42 is attached to the first end 34 and fluid infused into the flexible infusion port 30 is delivered to another site within the patient's body. Catheter 42 can be formed from silicone rubber and other biocompatible polymers well known in the art that can be utilized with conventional infusion ports such as those shown in FIGS. A tether portion 38 having an eye loop 40 extends from the second end 36. The surgeon can easily place the flexible injection port 30 in the body by grasping the tether 38 using a conventional surgical grasping device, tying a suture to the eye loop 40, or combining the grasping device and the suture. Can do.

  The flexible injection port 30 shown in FIG. 3 is substantially straight, but is flexible to facilitate placement within the patient's body or to conform to the body structure of the implantation site. The sex injection port 30 can be curved or non-linear. Because the flexible injection port 30 is formed from a relatively soft flexible material, the surgeon can be temporarily straightened when introduced into the body, for example, via a laparoscopic port.

  FIG. 4 is a cross-sectional view of the flexible injection port 30 taken along line 4-4 of the injection portion 32 shown in FIG. At this position and at any position in the length of the injection portion 32, the flexible injection port 30 includes an outer tube 44 that can radially compress the inner tube 46. The flexible infusion port 30 includes a fluid reservoir 48 that communicates with the catheter 42 and extends the entire length of the infusion portion 32. The total thickness of the wall is in the range of about 2-4 mm.

  FIG. 5 is a longitudinal sectional view of the flexible injection port 30. The hypodermic needle 100 is inserted into the injection portion 32, and the distal end 102 of the hypodermic needle 100 is located in the fluid reservoir 48. The first end 34, the second end 36, the tether 38, the eye loop 40, and the inner tube 46 are integrally formed from an elastomer such as silicone rubber, latex rubber, or polyurethane rubber. The molded elastomer has a durometer hardness in the range of 40-60, although not limited thereto. The catheter 42 can be coupled to the inside of the first end 34 and communicated with the reservoir 48 using one of various adhesives and techniques well known in the art. The outer tube 44 can be formed from PTFE shrinkable material or similar biocompatible shrinkable material. During the manufacturing process, the outer tube 44 can be loosely attached around the inner tube 46 in a pre-shrink structure. Heat is then applied to closely fit the outer tube 44 around the inner tube 46. Accordingly, the outer tube 44 applies a considerable compression force to the soft inner tube 46, whereby the inner tube 46 can easily close the puncture hole formed by the hypodermic needle 100.

  FIG. 6 is a cross-sectional view of a flexible injection port 50 that is a second embodiment of the present invention that is similar in appearance to the first embodiment shown in FIG. The flexible injection port 50 includes an outer tube 52, an inner tube 54, and an inner lining 56. The outer tube 52 and the inner tube 54 are respectively the same as the outer tube 44 and the inner tube 46 of the first embodiment of FIG. The inner lining 56 can be a thin tube of extruded plastic, such as polyethylene or PTFE, fitted tightly to the inner tube 54 to support the inner tube 54 from the inside. By supporting the inner tube 54 in this way, the pressing force of the outer tube 52 against the inner tube 54 is increased, and self-sealing property can be promoted. The material of the inner lining 56 can be selected to have higher needle penetration resistance than the inner tube 54. This difference in penetration resistance allows the surgeon to feel that the needle tip has penetrated into the fluid reservoir 58. The inner lining 56 can also be formed from a metal mesh and can be similar in many respects to a vascular stent. Again, the total thickness of the wall is in the range of about 2-4 mm.

  FIG. 7 is a cross-sectional view of a flexible injection port 60 that is a third embodiment of the present invention that is similar in appearance to the first embodiment shown in FIG. The flexible injection port 60 includes a plurality of layers 61. In the third embodiment, the plurality of layers 61 includes a first layer 62, a second layer 64, a third layer 66, a fourth layer 68, and a fifth layer 70 that covers the fluid reservoir. . When the needle is inserted at a steep angle, since the puncture holes formed in the plurality of layers are not aligned, no leakage occurs even if the needle is pulled out. Each layer of the plurality of layers 61 can be formed of the same or different material as the other layers of the plurality of layers 61. Each layer of the plurality of layers 61 has specific characteristics and contributes functionally. For example, the first layer 62 can be formed of a material that can be permeated by tissue fluid to release the drug contained in the second layer 64. The fifth layer 70 can be formed from silicone rubber having a durometer hardness in the range of 20-30. The fourth layer 68 can be formed from a heat-shrinkable PTFE material that radially compresses the fifth layer 70 to enhance self-sealing. The third layer 66 can be formed from a material such as a metal foil that functions as a diffusion barrier and prevents fluid loss from the fluid reservoir 72. The second layer 64 can be formed from a silicone rubber having a high durometer hardness. Because many other materials can be used in various combinations, the injection port 60 can have properties that are particularly suitable for a particular application. Diffusion of body fluids from (to) the soft port wall can be reduced by various metal processing techniques, including, for example, the deposition of titanium or other metals on the surface of the soft port, and coating with a paralene polymer. Can do. Other coatings for protection from microbacteria are also known in the art. Again, the total thickness of the wall is in the range of 2-4 mm.

  FIG. 8 shows a flexible injection port 80 according to a fourth embodiment of the present invention. The flexible infusion port 80 includes a first end 84, a second end 86, and an infusion portion 82 attached to the catheter 92. The flexible injection port 80 further includes a web forming portion 88 attached to the injection portion 82. The web forming portion 88 covers at least the injection portion 82 and is formed from a thin flexible implantable material such as polyester or polypropylene mesh and expanded PTFE. The web-forming portion 88 also provides a wide margin for stapling or suturing subcutaneous tissue such as fascia, as well as a large area for tissue ingrowth to promote long-term stability and flexibility The displacement of the injection port 80 is substantially prevented. FIG. 9 is a cross-sectional view of the flexible injection port 80 taken along line 9-9 of FIG. The flexible injection port 80 includes an outer tube 94 made of heat shrinkable PTFE material and an inner tube 96 made of silicone rubber having a durometer hardness of about 20-40. The web forming part 88 includes a pair of web forming layers 91 and 93. These web forming layers can be thermally or chemically tightly bonded at least in the midplane of the flexible injection port 80 over the injection portion 82.

  The surgeon can implant the present invention, ie, the embodiments described above, or equivalents thereof at various sites within the patient's body. 10-12 illustrate an example of a flexible infusion port 30 implanted subcutaneously in the patient's abdomen. However, the flexible injection port 30 can also be implanted in other subcutaneous parts of the body.

  FIG. 10 shows a first example of a flexible injection port 30 implanted subcutaneously in a patient's body. The flexible injection port 30 extends in the vicinity of the fascial layer 124 that covers the abdominal wall 126. A catheter 42 extends from the abdominal cavity 128 through the abdominal opening 132. This abdominal opening 132 was used with the first incision 130 for laparoscopic access in a surgical procedure prior to the surgeon. The surgeon may optionally form a second incision 134 remote from the first incision 130 and use a conventional surgical grasping device and retractor to approach the fascia 124 below the fat layer 122. The flexible injection port 30 can be pulled. However, the surgeon may decide not to form the second incision 134 and instead use the first incision 130 to push the flexible injection port 30 into place. In either case, the surgeon minimizes incision as much as possible to shorten the time of operation and minimize the size of the closed body cavity where tissue fluid can accumulate and become the site of infection. The surgeon can optionally secure the flexible injection port 30 to the fascial layer 124 using an indwelling suture 104. Once the surgeon has placed the flexible injection port 30 at the desired site, the surgeon closes the first incision 130 and the second incision 134 using conventional sutures or staples.

  FIG. 11 shows a second example of a flexible injection port 30 implanted subcutaneously in a patient's body. The flexible injection port 30 extends on top of the fat layer 122 just below the skin layer 120. A catheter 42 extends into the abdominal cavity 128 through the first incision and abdominal opening 132 (originally a laparoscopic port site). The surgeon uses the finger or instrument through the first incision 130 to create a space for the flexible injection port 30 below the skin layer 120. The surgeon closes the first incision 130 using conventional sutures or staples. Normally, it is not necessary to close the abdominal opening 132 through the fascial layer 124 and the abdominal wall 126, but the abdominal opening 132 may be used to promote healing and prevent the catheter 42 from moving out of the abdominal opening 132. It can also be closed. For extremely obese patients where the thickness of the fat layer 122 exceeds 5-10 cm, the surgeon can easily locate the flexible injection port 30 by palpation during subsequent fluid injections. Often it is chosen to place the flexible injection port 30 directly underneath. Also, using conventional intravenous (IV) needles and techniques, fluid can be injected into the flexible injection port 30 that is subcutaneous and resembles a natural blood vessel. In this way, nurses and other clinicians trained in intravenous injection can assist the surgeon with fluid injection. In addition, if the clinician uses a conventional IV needle, the backflow of fluid into the syringe tip of the IV needle has indicated that the clinician has properly inserted the needle tip into the reservoir of the flexible injection port 30. The feedback is visible. Indeed, the addition of colorant to the fluid to be injected can facilitate this visual feedback. Non-toxic colorants that can be added to saline or drugs are well known in the art.

  FIG. 12 shows a third example of a flexible injection port 30 implanted subcutaneously in a patient's body. In this example, the surgeon may have no or little tissue incision at the laparoscopic port site. A catheter 42 extends from the abdominal cavity 128 through the fascial layer 124 and the abdominal wall 126. The surgeon places the flexible injection port 30 vertically in the fat layer 122 below the skin layer 120. The surgeon can optionally suture the abdominal opening 132 to prevent the flexible injection port 30 from moving into the abdominal cavity 128. The surgeon can also cut the tether 38 from the flexible injection port 30 with a surgical scissor just prior to closing the first incision 130 with a conventional suture or staple.

  The flexible injection port of the present invention described above using the above-described embodiment and its equivalents have various advantages over the conventional injection port. Since the flexible injection port does not have to be attached to the fascia, the surgeon treatment time can be reduced. In this flexible injection port, the incision for transplantation is small and the incision of tissue is small, so that the patient suffers less, scars are less, laparotomy is faster, and the risk of infection is small. Because the flexible infusion port and catheter are a unitary structure, there is no need to connect the catheter to the infusion port during the surgical procedure, reducing the risk of various surgical complications due to fluid leakage at the junction. A flexible infusion port can be implanted in the fat layer near the skin surface, allowing surgeons or trained clinicians to locate the infusion port by palpation and administer fluid using standard IV techniques And the transplant is cosmetically acceptable to the patient. In addition, since a short injection needle can be used for fluid administration, patient anxiety can be reduced. The flexible injection port does not have to have a metal part, thus enabling a light and flexible implant, which improves patient experience and is also compatible with magnetic resonance and fluoroscopy It is sex. Finally, the hypodermic needle can access the infusion portion of the flexible infusion port in most possible orientations of the flexible infusion port placed in the patient's subcutaneous fat layer.

  While preferred embodiments of the present invention have been illustrated and described, those skilled in the art will appreciate that such embodiments are merely illustrative. Those skilled in the art will readily envision various modifications, variations, and substitutions without departing from the invention. For example, the injection port can be provided with an antimicrobial coating such as triclosan. As will be apparent to those skilled in the art, for example, the disclosure herein is equally applicable to robot-assisted surgery. In addition, it should be understood that each of the structures described above has a function, and that these structures can be viewed as a means for performing that function. Accordingly, the invention is limited only by the following claims and concepts.

Embodiments of the present invention are as follows.
(1) A method of subcutaneously implanting an injection port used with a medical device for transplantation into the body,
(A) a first end, a second end, a wall extending between these ends and self-sealing after insertion, and a substantially soft having a fluid reservoir surrounded by said wall A spout providing an infusion port including a flexible elongate body and a flexible elongate tube catheter attached to the body in communication with the reservoir;
(B) forming an incision for laparoscopic access to the abdominal cavity of the patient;
(C) accessing the patient's subcutaneous fat layer through the incision;
(D) forming a space in the subcutaneous fat layer;
(E) placing the flexible injection port in the space of the subcutaneous fat layer;
(F) closing the incision.
(2) The method of embodiment (1), further comprising attaching the flexible injection port to a fascial layer of the abdominal wall.
(3) A method of subcutaneously implanting an injection port used with a medical device for transplantation into the body,
(A) a first end, a second end, a wall extending between these ends and self-sealing after insertion, and a substantially soft having a fluid reservoir surrounded by said wall A spout providing an infusion port including a flexible elongate body and a flexible elongate tube catheter attached to the body in communication with the reservoir;
(B) forming an incision in the patient's body;
(C) accessing the patient's subcutaneous fat layer through the incision;
(D) forming a space in the subcutaneous fat layer so that the injection port can be confirmed by external palpation, and implanting the injection port in the subcutaneous fat layer;
(E) closing the incision.

1 is an isometric view of a prior art injection port. FIG. 2 is a cross-sectional view of the prior art injection port shown in FIG. 1 is an isometric view of a flexible injection port 30 according to a first embodiment. FIG. FIG. 4 is a cross-sectional view of the flexible injection port 30 shown in FIG. 3. FIG. 3 is an enlarged side cross-sectional view of a flexible injection port 30 into which a hypodermic needle 100 is inserted. It is an isometric view of the flexible injection port 50 which is 2nd Embodiment. It is an isometric view of the flexible injection port 60 which is 3rd Embodiment. FIG. 6 is an isometric view of a flexible injection port 80 according to a fourth embodiment. 3 is a cross-sectional view of flexible injection port 80. FIG. It is a schematic diagram of the injection port 30 implanted subcutaneously in the vicinity of the patient's fascial layer 124. 2 is a schematic view of an injection port 30 implanted subcutaneously in the vicinity of a patient's skin layer 120. FIG. 1 is a schematic diagram of an injection port 30 implanted subcutaneously in a fat layer 122 of a patient. FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Injection port 12 Body part 14 Housing 16 Seal member 18 Catheter part 20 Cavity 22 Catheter support part 24 Passage 30, 50, 60, 80 Injection port 32, 82 Injection part 34, 84 1st end part 36, 86 2nd End portion 38 Connecting portion 40 Eye loop 42, 92 Catheter 44, 94 Outer tube 46, 96 Inner tube 48, 58, 72 Reservoir 52 Inner tube 54 Outer tube 56 Inner lining 61 Multiple layers 62 First layer 64 Second layer 66 3rd layer 68 4th layer 70 5th layer 88 webbed forming portion 91, 93 webbed forming layer 100 hypodermic needle 102 hypodermic needle tip 104 indwelling suture 120 skin layer 122 fat layer 124 fascial layer 126 abdominal wall 128 abdominal cavity 130 first incision 132 abdomen The opening of

Claims (3)

A method of subcutaneously implanting an injection port for use with a medical device for implantation into the body,
(A) a first end, a second end, a wall extending between these ends and self-sealing after insertion, and a substantially soft having a fluid reservoir surrounded by said wall A spout providing an infusion port including a flexible elongate body and a flexible elongate tube catheter attached to the body in communication with the reservoir;
(B) forming an incision for laparoscopic access to the abdominal cavity of the patient;
(C) accessing the patient's subcutaneous fat layer through the incision;
(D) forming a space in the subcutaneous fat layer;
(E) placing the flexible injection port in the space of the subcutaneous fat layer;
(F) closing the incision.   The method of claim 1, further comprising attaching the flexible injection port to a fascial layer of the abdominal wall. A method of subcutaneously implanting an injection port for use with a medical device for implantation into the body,
(A) a first end, a second end, a wall extending between these ends and self-sealing after insertion, and a substantially soft having a fluid reservoir surrounded by said wall A spout providing an infusion port including a flexible elongate body and a flexible elongate tube catheter attached to the body in communication with the reservoir;
(B) forming an incision in the patient's body;
(C) accessing the patient's subcutaneous fat layer through the incision;
(D) forming a space in the subcutaneous fat layer so that the injection port can be confirmed by external palpation, and implanting the injection port in the subcutaneous fat layer;
(E) closing the incision.

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